PROSTHESIS - CAPCEL 1112197

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-05-23 for PROSTHESIS - CAPCEL 1112197 manufactured by Medtronic Xomed Inc..

Event Text Entries

[45714077] Product evaluation: analysis results not available; evaluation expected but not yet begun.
Patient Sequence No: 1, Text Type: N, H10


[45714078] It was reported that during implantation, "the polycel shaft broke off from the titanium shaft connection to the head. All portions of the broken implant were removed from the patient. " there was no patient impact; a different product was used in its place.
Patient Sequence No: 1, Text Type: D, B5


[46014864] Date of this report: 4/29/2016. Date manufacturer received: 5/24/2016. Product evaluation: the product is shipped in a ridged capsule which likely indicates the devices were not damaged in shipping. When compared to the assembly drawing: visually, the polycel had separated from the stainless steel cores which would have resulted in the reported event. The core is imbedded into the polycel by approximately 0. 012? Deep according to the drawing and polycel is porous structural foam which makes it susceptible to any sort of mishandling. It was reported that the devices broke during implantation and there was no allegation that they were broke prior to handling. The complaint was confirmed for the alleged malfunction [detached]. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[102515400] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1045254-2016-00161
MDR Report Key5673631
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-05-23
Date of Report2016-04-29
Date of Event2016-04-28
Date Mfgr Received2016-05-24
Device Manufacturer Date2015-08-31
Date Added to Maude2016-05-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICHELLE ALFORD
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328197
Manufacturer G1MEDTRONIC XOMED INC.
Manufacturer Street6743 SOUTHPOINT DR NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal Code32216
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROSTHESIS - CAPCEL
Generic NameREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
Product CodeETA
Date Received2016-05-23
Returned To Mfg2016-05-18
Model Number1112197
Catalog Number1112197
Lot Number0210073879
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC XOMED INC.
Manufacturer Address6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US 32216


Patients

Patient NumberTreatmentOutcomeDate
10 2016-05-23

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